
Article 1 
The approval of the active substance silthiofam is renewed as set out in Annex I.
Article 2 
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 July 2018.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 14 May 2018.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX I

Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions
SilthiofamCAS No 175217-20-6CIPAC No 635 N-allyl-4,5-dimethyl-2-(trimethylsilyl)thiophene-3-carboxamide ≥ 980 g/kg 1 July 2018 30 June 2033 For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on silthiofam and in particular Appendices I and II thereof, shall be taken into account.In their overall assessment Member States shall pay particular attention to:
— the protection of operators,
— the protection of groundwater in vulnerable regions,
— the protection of birds, mammals and earthworms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:
1.. the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater are abstracted for drinking water;
2.. the relevance of the metabolites M2 and M6 taking into account any relevant classification for silthiofam in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council, in particular as reprotoxic category 2.The applicant shall submit the information mentioned in point (1) within two years after a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater is made public by the Commission and the information requested under point (2) within one year after the publication in the European Chemicals Agency (ECHA) webpage of the opinion adopted by the Committee for risk assessment of the ECHA in accordance with Article 37(4) of Regulation (EC) No 1272/2008 with respect to silthiofam.


ANNEX II

The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

((1)) in Part A, the entry 70 for Silthiofam is deleted;
((2)) in Part B, the following entry is added:

No Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions
‘121 SilthiofamCAS No 175217-20-6CIPAC No 635 N-allyl-4,5-dimethyl-2-(trimethylsilyl)thiophene-3-carboxamide ≥ 980 g/kg 1 July 2018 30 June 2033 For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on silthiofam and in particular Appendices I and II thereof, shall be taken into account.In their overall assessment Member States shall pay particular attention to:
— the protection of operators,
— the protection of groundwater in vulnerable regions,
— the protection of birds, mammals and earthworms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:
1.. the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater are abstracted for drinking water;
2.. the relevance of the metabolites M2 and M6 taking into account any relevant classification for silthiofam in accordance with Regulation (EC) No 1272/2008, in particular as reprotoxic category 2.The applicant shall submit the information mentioned in point (1) within two years after a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater is made public by the Commission and the information requested under point (2) within one year after the publication in the European Chemicals Agency (ECHA) webpage of the opinion adopted by the Committee for risk assessment of the ECHA in accordance with Article 37(4) of Regulation (EC) No 1272/2008 with respect to silthiofam.’

